Since August 2015, Amgen and Apotex have been locked in litigation in the US District Court for the Southern District of Florida related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Amgen’s Neulasta®. As explained in a previous post, what is unique about this suit, is that Amgen brought suit after they and Apotex actually participated in the “patent dance” as set forth in 42 USC §§ 262(l (2)-(5) of the Biologics Price Competition and Innovation Act (BPCIA).

On Wednesday, the Federal judge held that regardless of whether a biosimlar applicant participates in the patent dance, they must always provide 180 days notice of commercial marketing upon licensure to the reference product sponsor (RPS). The ruling was the first to address a key question left open by the Court of Appeals for the Federal Circuit’s Amgen v. Sandoz decision regarding interpretation of the notice provisions of the BPCIA. While the Federal Circuit made clear that 180 day notice could only be effective upon licensure if the patent dance were bypassed, they seemed to suggest that notice might not be mandatory if biosimilar applicants comply with the patent dance.